Talent.com
Senior Clinical Data Manager
Senior Clinical Data ManagerEverest Clinical Research Services Inc. • Markham, York Region, CA
Senior Clinical Data Manager

Senior Clinical Data Manager

Everest Clinical Research Services Inc. • Markham, York Region, CA
13 days ago
Job type
  • Full-time
Job description

Ontario, 675 Cochrane Drive, East Tower 4th Floor, Markham, ON L3R0B8, CAN.

Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer‑focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

Senior Clinical Data Managers

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for our Toronto / Markham, Ontario, Canada on‑site location, or remotely from a home‑based office anywhere in Canada in accordance with our Work from Home policy.

Lead Data Management Activities, Perform Training and Client Relationship Management

  • Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
  • Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
  • Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
  • Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
  • Assist with study‑level resource planning and management, including the review of team members’ timesheet reports.
  • Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
  • Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
  • Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
  • Assist in generation of project Work Orders and Amendments.
  • Assist in management of dataflow from and performance of Third Party Vendors (Non‑CRF data vendors).
  • Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
  • Provide support to client audits and regulatory inspections. Follow up on audit findings.
  • Create and maintain clinical trial Data Management Study Binders.

Perform Hands‑on Data Management Activities

  • Design and review case report forms (CRFs / eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
  • Design and review Clinical Trial Source Document templates and completion instructions when required.
  • Develop and maintain data validation specifications.
  • Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.
  • Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).
  • Manage the process of database modifications (after go‑live) due to protocol amendments or study needs.
  • Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
  • Perform Third Party non‑CRF data management activities.
  • Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
  • Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
  • Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.
  • Perform database soft‑lock and hard lock activities.
  • Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.
  • Qualifications and Experience

  • A Bachelors’ or Master’s degree in health and / or pharmaceutical sciences, physical / biological, or chemistry fields.
  • At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 years of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction.
  • Demonstrated an in‑depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards.
  • Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects.
  • Estimated Salary Range : $100,000 – $130,000.

    We thank all interested applicants, however, only those selected for an interview will be contacted.

    Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

    To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com.

    #J-18808-Ljbffr

    Create a job alert for this search

    Senior Clinical Data Manager • Markham, York Region, CA

    Similar jobs
    Senior Manager, Data & Vendor Risk

    Senior Manager, Data & Vendor Risk

    CIRO / OCRI • Toronto C6A, ON, Canada
    Remote
    Full-time
    Senior Manager, Data & Vendor Risk.The Senior Manager, Data & Vendor Risk manages second line oversight activities for Data, Vendor, and Information Security Risk. This role initially serves as the ...Show more
    Last updated: 30+ days ago • Promoted
    Sr. Manager, Data Scientist

    Sr. Manager, Data Scientist

    Rogers Communications, Inc. • Toronto C6A, ON, Canada
    Full-time +1
    Select how often (in days) to receive an alert : .Our Technology team wakes up every day with one goal in mind - connecting Canadians to the people and things that matter most.Together, we are proud ...Show more
    Last updated: 8 days ago • Promoted
    Senior Analytics Lead, Clinical Operations & Insights

    Senior Analytics Lead, Clinical Operations & Insights

    Moderna • Toronto
    Full-time
    A pioneering biotech company in Toronto is seeking an experienced analytics professional to transform clinical development through advanced data systems. The role involves designing systems for pred...Show more
    Last updated: 16 hours ago • Promoted • New!
    AI Consulting Senior Manager

    AI Consulting Senior Manager

    Ontario Teachers' Pension Plan • Toronto, ON, Canada
    Full-time
    The Senior Manager, Workflow Optimization & AI Enablement plays a critical role in driving enterprise AI adoption and process optimization across the organization. This hands‑on position is responsi...Show more
    Last updated: 3 days ago • Promoted
    Manager (or Senior Manager), Scientific Research & Experimental Development

    Manager (or Senior Manager), Scientific Research & Experimental Development

    MNP • Markham
    Full-time
    Inspirational, innovative and entrepreneurial - this is how we describe our empowered teams.Combine your passion with purpose and join a culture that is thriving in the face of change.Make an impac...Show more
    Last updated: 21 hours ago • Promoted • New!
    Senior Manager, Data Quality

    Senior Manager, Data Quality

    Aviva plc • Markham
    Full-time
    Senior Manager, Data Quality page is loaded## Senior Manager, Data Qualitylocations : Markham : Torontoposted on : Publié aujourd'huijob requisition id : R-162878# Experience AvivaIndividually ...Show more
    Last updated: 22 hours ago • Promoted • New!
    Manager, Data

    Manager, Data

    Scotiabank • Toronto, On
    Full-time
    Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.The Manager, Data & Analytics, Retail Credit Risk, GRM, is responsible for monitoring, cond...Show more
    Last updated: 16 hours ago • Promoted • New!
    Senior Territory Manager, Endoscopy

    Senior Territory Manager, Endoscopy

    Boston Scientific • Toronto C6A, ON, Canada
    Full-time
    Additional Locations : Canada-ON-Toronto; Canada-ON-Mississauga.Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance. At Boston Scientific, we’ll give you the op...Show more
    Last updated: 6 days ago • Promoted
    Senior Manager - Regulatory Data Monitoring Development & Delivery

    Senior Manager - Regulatory Data Monitoring Development & Delivery

    RBC • Toronto
    Full-time
    This role is responsible for creating data‑based detective controls to mitigate regulatory compliance and financial reporting risks. As a PB & CB Data Subject Matter Expert (SME), it contributes to ...Show more
    Last updated: 21 hours ago • Promoted • New!
    Senior Technical Product Manager : AI & Data Platforms

    Senior Technical Product Manager : AI & Data Platforms

    RPM Freight Systems • Toronto C6A, ON, Canada
    Remote
    Full-time
    A leading technology firm in Toronto seeks a Senior Technical Product Manager to drive technical product strategy and execution. This role requires a solid understanding of complex systems, AI featu...Show more
    Last updated: 19 days ago • Promoted
    People Consulting - Senior Manager Change Management for Clinical Information System Toronto

    People Consulting - Senior Manager Change Management for Clinical Information System Toronto

    Ernst & Young Advisory Services Sdn Bhd • Toronto, ON, Canada
    Full-time
    People Consulting - Senior Manager Change Management for Clinical Information System Toronto.Other locations : Primary Location Only. At EY, we’re all in to shape your future with confidence.We’ll he...Show more
    Last updated: 5 days ago • Promoted
    Senior Manager, Clinic Operations & Transformation

    Senior Manager, Clinic Operations & Transformation

    Medcan • Toronto
    Full-time
    A healthcare services provider in Toronto is seeking a Senior Manager, Operations (Clinic Services) to oversee and optimize clinic operations. The role involves strategic leadership, enhancing clien...Show more
    Last updated: 16 hours ago • Promoted • New!
    Clinical Lead - Home Health, Hybrid (60% Field)

    Clinical Lead - Home Health, Hybrid (60% Field)

    Bayshore HealthCare • Toronto C6A, ON, Canada
    Remote
    Full-time
    A community health organization is seeking a Clinical Lead in Toronto to oversee personalized home care.In this hands-on role, you will develop care plans, manage field staff, and ensure exceptiona...Show more
    Last updated: 30+ days ago • Promoted
    Senior Product Manager – Global Data Platform

    Senior Product Manager – Global Data Platform

    BioTalent Canada • Toronto C6A, ON, Canada
    Full-time
    Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of tra...Show more
    Last updated: 11 days ago • Promoted
    Senior Manager, Compensation — Hybrid & Data-Driven

    Senior Manager, Compensation — Hybrid & Data-Driven

    Bell Canada • Toronto
    Full-time
    A leading telecom company is seeking a Senior Manager, Compensation, to manage payments and data analytics for media distribution channels. The ideal candidate has strong SQL skills and is proficien...Show more
    Last updated: 15 days ago • Promoted
    Technical Product Manager : AI-Driven Data Infra, Hybrid

    Technical Product Manager : AI-Driven Data Infra, Hybrid

    Shyftlabs • Toronto C6A, ON, Canada
    Remote
    Full-time
    A fast-growing startup is seeking a seasoned Technical Product Manager in Toronto to lead the end-to-end lifecycle of high-impact technical initiatives. In this role, you will define technical strat...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Director, Medicine & Mental Health Programs

    Clinical Director, Medicine & Mental Health Programs

    Southlake Regional Health Centre • Newmarket L0G, ON, Canada
    Full-time +1
    Job Category : Leadership### ### Hospital Location : Newmarket ON### ### Job Type : Permanent, Full time### ### ### ### Number of Positions : 1### ### Minimum - Maximum Hourly Rate : $82.A best-in-class...Show more
    Last updated: 22 days ago • Promoted
    Clinical Trial Master File (TMF) Manager - toronto

    Clinical Trial Master File (TMF) Manager - toronto

    Nexcella, Inc. • toronto, on, ca
    Full-time
    Clinical Trial Master File (TMF) Manager.Greater Montreal Area / Hybrid.Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessib...Show more
    Last updated: 2 days ago • Promoted